BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TC MONITOR

    MDR report key: 575957 · Received February 9, 2005

    Report

    Report Number
    3002807968-2005-00001
    Event Type
    Malfunction
    Date Received
    February 9, 2005
    Report Date
    February 4, 2005
    Manufacturer
    RADIOMETER MEDICAL APS
    Product Code
    KLK
    Removal / Correction Number
    3002807968-02/02/2005-00
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    IT HAS BEEN DISCOVERED WITHIN RADIOMETER, THAT A RAPID SWITCHING OF THE INSTRUMENT OFF AND ON MAY CAUSE THE BUILD-IN ACOUSTICAL ALARM TO REMAIN SILENT WHEN TRIPPED. THE VISUAL ALARM REMAINS UNAFFECTED. RADIOMETER HAS RECEIVED NO REPORTS ABOUT THIS FROM THE FIELD AND NO HARM TO ANY PT HAS OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TC MONITOR TRANSCUTANEOUS OXYGEN AND CARBONDIOXIDE MONI KLK RADIOMETER MEDICAL APS TCM4 *

    Patients

    Seq Age Sex Outcome Treatment
    1 *